FDG-PET/CT for Response Monitoring in Metastatic Breast Cancer: The Feasibility and
      Benefits of Applying PERCIST

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Abstract

Background: We aimed to examine the feasibility and potential benefit of applying PET Response Criteria in Solid Tumors (PERCIST) for response monitoring in metastatic breast cancer (MBC). Further, we introduced the nadir scan as a reference. Methods: Response monitoring FDG-PET/CT scans in 37 women with MBC were retrospectively screened for PERCIST standardization and measurability criteria. One-lesion PERCIST based on changes in SULpeak measurements of the hottest metastatic lesion was used for response categorization. The baseline (PERCIST _baseline) and the nadir scan (PERCIST _nadir) were used as references for PERCIST analyses. Results: Metastatic lesions were measurable according to PERCIST in 35 of 37 (94.7%) patients. PERCIST was applied in 150 follow-up scans, with progression more frequently reported by PERCIST _nadir (36%) than PERCIST _baseline (29.3%; p = 0.020). Reasons for progression were (a) more than 30% increase in SUL _peak of the hottest lesion ( n = 7, 15.9%), (b) detection of new metastatic lesions ( n = 28, 63.6%), or both (a) and (b) ( n = 9, 20.5%). Conclusions: PERCIST, with the introduction of PERCIST _nadir, allows a graphical interpretation of disease fluctuation that may be beneficial in clinical decision-making regarding potential earlier termination of non-effective toxic treatment. PERCIST seems feasible for response monitoring in MBC but prospective studies are needed to come this closer.

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Most cited references 22

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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

E A Eisenhauer, P Therasse, J Bogaerts … (2009)

Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.

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Breast cancer

Nadia Harbeck, Frederique Penault-Llorca, Javier Cortés … (2019)

Breast cancer is the most frequent malignancy in women worldwide and is curable in ~70-80% of patients with early-stage, non-metastatic disease. Advanced breast cancer with distant organ metastases is considered incurable with currently available therapies. On the molecular level, breast cancer is a heterogeneous disease; molecular features include activation of human epidermal growth factor receptor 2 (HER2, encoded by ERBB2), activation of hormone receptors (oestrogen receptor and progesterone receptor) and/or BRCA mutations. Treatment strategies differ according to molecular subtype. Management of breast cancer is multidisciplinary; it includes locoregional (surgery and radiation therapy) and systemic therapy approaches. Systemic therapies include endocrine therapy for hormone receptor-positive disease, chemotherapy, anti-HER2 therapy for HER2-positive disease, bone stabilizing agents, poly(ADP-ribose) polymerase inhibitors for BRCA mutation carriers and, quite recently, immunotherapy. Future therapeutic concepts in breast cancer aim at individualization of therapy as well as at treatment de-escalation and escalation based on tumour biology and early therapy response. Next to further treatment innovations, equal worldwide access to therapeutic advances remains the global challenge in breast cancer care for the future.

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From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors.

Richard L. Wahl, Heather Jacene, Yvette Kasamon … (2009)

The purpose of this article is to review the status and limitations of anatomic tumor response metrics including the World Health Organization (WHO) criteria, the Response Evaluation Criteria in Solid Tumors (RECIST), and RECIST 1.1. This article also reviews qualitative and quantitative approaches to metabolic tumor response assessment with (18)F-FDG PET and proposes a draft framework for PET Response Criteria in Solid Tumors (PERCIST), version 1.0. PubMed searches, including searches for the terms RECIST, positron, WHO, FDG, cancer (including specific types), treatment response, region of interest, and derivative references, were performed. Abstracts and articles judged most relevant to the goals of this report were reviewed with emphasis on limitations and strengths of the anatomic and PET approaches to treatment response assessment. On the basis of these data and the authors' experience, draft criteria were formulated for PET tumor response to treatment. Approximately 3,000 potentially relevant references were screened. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria is widely applied but still has limitations in response assessments. For example, despite effective treatment, changes in tumor size can be minimal in tumors such as lymphomas, sarcoma, hepatomas, mesothelioma, and gastrointestinal stromal tumor. CT tumor density, contrast enhancement, or MRI characteristics appear more informative than size but are not yet routinely applied. RECIST criteria may show progression of tumor more slowly than WHO criteria. RECIST 1.1 criteria (assessing a maximum of 5 tumor foci, vs. 10 in RECIST) result in a higher complete response rate than the original RECIST criteria, at least in lymph nodes. Variability appears greater in assessing progression than in assessing response. Qualitative and quantitative approaches to (18)F-FDG PET response assessment have been applied and require a consistent PET methodology to allow quantitative assessments. Statistically significant changes in tumor standardized uptake value (SUV) occur in careful test-retest studies of high-SUV tumors, with a change of 20% in SUV of a region 1 cm or larger in diameter; however, medically relevant beneficial changes are often associated with a 30% or greater decline. The more extensive the therapy, the greater the decline in SUV with most effective treatments. Important components of the proposed PERCIST criteria include assessing normal reference tissue values in a 3-cm-diameter region of interest in the liver, using a consistent PET protocol, using a fixed small region of interest about 1 cm(3) in volume (1.2-cm diameter) in the most active region of metabolically active tumors to minimize statistical variability, assessing tumor size, treating SUV lean measurements in the 1 (up to 5 optional) most metabolically active tumor focus as a continuous variable, requiring a 30% decline in SUV for "response," and deferring to RECIST 1.1 in cases that do not have (18)F-FDG avidity or are technically unsuitable. Criteria to define progression of tumor-absent new lesions are uncertain but are proposed. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria have limitations, particularly in assessing the activity of newer cancer therapies that stabilize disease, whereas (18)F-FDG PET appears particularly valuable in such cases. The proposed PERCIST 1.0 criteria should serve as a starting point for use in clinical trials and in structured quantitative clinical reporting. Undoubtedly, subsequent revisions and enhancements will be required as validation studies are undertaken in varying diseases and treatments.

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Author and article information

Contributors

Hidehiko Okazawa: Role: Academic Editor

Journal

Journal ID (nlm-ta): Diagnostics (Basel)

Journal ID (iso-abbrev): Diagnostics (Basel)

Journal ID (publisher-id): diagnostics

Title: Diagnostics

Publisher: MDPI

ISSN (Electronic): 2075-4418

Publication date (Electronic): 19 April 2021

Publication date Collection: April 2021

Volume: 11

Issue: 4

Electronic Location Identifier: 723

Affiliations

[1 ]Department of Nuclear Medicine, Odense University Hospital, DK-5000 Odense, Denmark; jakob.lykke.bulow2@ 123456rsyd.dk (J.L.B.); lasse.ljungstrom@ 123456rsyd.dk (L.L.); hjalte.rasmus.oltmann@ 123456rsyd.dk (H.R.O.); tural.asgharzadeh.alamdari@ 123456rsyd.dk (T.A.A.); mohammad.naghavi-behzad2@ 123456rsyd.dk (M.N.-B.); poul-erik.braad@ 123456rsyd.dk (P.-E.B.); oke.gerke@ 123456rsyd.dk (O.G.); malene.grubbe.hildebrandt@ 123456rsyd.dk (M.G.H.)

[2 ]Department of Oncology, Odense University Hospital, DK-5000 Odense, Denmark

[3 ]Department of Clinical Research, University of Southern Denmark, DK-5000 Odense, Denmark

[4 ]Open Patient Data Explorative Network, Odense University Hospital, DK-5000 Odense, Denmark

[5 ]Centre for Personalized Response Monitoring in Oncology, Odense University Hospital, DK-5000 Odense, Denmark

[6 ]Centre for Innovative Medical Technology, Odense University Hospital, DK-5000 Odense, Denmark

Author notes

[* ]Correspondence: marianne.vogsen@ 123456rsyd.dk

Author information

Marianne Vogsen https://orcid.org/0000-0002-6124-4063

Tural Asgharzadeh Alamdari https://orcid.org/0000-0001-8949-5406

Mohammad Naghavi-Behzad https://orcid.org/0000-0002-6761-8126

Poul-Erik Braad https://orcid.org/0000-0003-4906-5422

Oke Gerke https://orcid.org/0000-0001-6335-3303

Malene Grubbe Hildebrandt https://orcid.org/0000-0003-2720-9018

Article

Publisher ID: diagnostics-11-00723

DOI: 10.3390/diagnostics11040723

PMC ID: 8073831

PubMed ID: 33921580

SO-VID: 4b90da30-5a2a-4603-a302-ce267e48457c

License:

Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( https://creativecommons.org/licenses/by/4.0/).

History

Date received : 15 March 2021

Date accepted : 16 April 2021

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FDG-PET/CT for Response Monitoring in Metastatic Breast Cancer: The Feasibility and Benefits of Applying PERCIST

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NeuroImaging Methods

Most cited references 22

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

Breast cancer

From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors.

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